Sr Principal Specialist, Regulatory Affairs - Pre Approval

Boehringer Ingelheim Duluth , GA 30198

Posted 2 months ago

Description:

Prepare, review and file regulatory submissions to FDA-CVM/EPA. Maintain working knowledge of regulations, policies, and guidelines with appropriate agencies for the purpose of providing leadership and guidance to the company in its efforts to obtain approval of new product registrations and of additional/extended claims for existing products. Guide the company in achieving product approvals, maintaining regulatory compliance and supporting local/global Pharma development teams.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities:

  • Prepare/ Review scientific/technical information related to regulatory submissions or regulatory compliance. Prepare/review/file regulatory dossiers which may include safety, efficacy and labeling submissions to FDA-CVM/EPA.

  • Provide guidance/direction/training within the regulatory department and to other departments relative to in-depth and current understanding of regulatory compliance, submission requirements, time lines or regulatory agency expectations.

  • Provide guidance and consultation on product development, including active project team participation/support.

  • Act as liaison to FDA-CVM/EPA and trade associations as requested. Understand/monitor regulatory trends and work with regulatory teams to influence legislation/guidance and to inform organization of new guidelines, directives, and agency initiatives.

  • Pro-actively identify and initiate departmental process improvements, draft and review departmental processes and SOPs for activities relevant to this position and leads special projects as assigned.

  • Align with global regulatory objectives and execute as per plan.

Requirements:

  • Advanced degree (Doctoral or Master's degree in relevant discipline) with Regulatory Affairs Certification (RAC) preferred.

  • Minimum eight (8) years pharmaceutical or related pre-approval regulatory experience (FDA-CVM experience required, EPA experience strongly preferred).

  • Multidisciplinary problem solving, time management and regulatory strategy skills.

  • Direct knowledge of regulatory requirements for demonstration of safety and effectiveness, including principles of study conduct, statistics and design.

  • High degree of detail orientation and excellent verbal and written communication skills.

  • Professional customer focused approach.

  • Prioritizes and works independently to meet or exceed agreed upon projects/timelines.

  • Project Management experience

Eligibility Requirements:

  • Must be legally authorized to work in the United States without restriction

  • Must be willing to take a drug test and post-offer physical (if required)

  • Must be 18 years of age or older

Our Culture:

Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighbourhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.


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Sr Principal Specialist, Regulatory Affairs - Pre Approval

Boehringer Ingelheim